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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 864: HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J: Products Used In Establishments That Manufacture Blood and Blood Products
864.9275 - Blood bank centrifuge for in vitro diagnostic use.
(a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to ? 864.9.
[45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]
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